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AdvanDx Receives FDA 510(k) Clearance for 90 Minutes Protocol for Yeast Traffic Light® PNA FISH®
Date:7/29/2010

ter, 90 minute protocol in just six months," said Thais T. Johansen, President and CEO of AdvanDx.  "Hospitals can now obtain accurate, actionable species identification results for the most common bloodstream pathogens in just 90 minutes, enabling clinicians to improve antimicrobial therapy, care and outcomes for their patients," Johansen concluded.

About Bloodstream Infections

Every year, close to 875,000 patients in the United States contract bloodstream infections, leading to over 150,000 deaths and significant costs to the healthcare system (5). The infection is detected when a culture of the patient's blood (i.e. a blood culture) turns positive with bacteria or yeast.  Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.

About AdvanDx

AdvanDx is the leading provider of advanced molecular diagnostic products for the diagnosis and treatment of life-threatening, bloodstream infections.  AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic improvements in patient care and help to save lives and reduce hospital costs.

AdvanDx's products employ standard laboratory techniques and equipment to reduce startup, implementation, technician and maintenance time, while providing fast results without sacrificing accuracy.  Major medical centers, reference labs, government institutions and community hospitals throughout the United States, Europe and Asia rely on AdvanDx products as integral parts of their medical care.

For more information visit

SOURCE AdvanDx
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1. AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures
2. Study Shows Use of AdvanDxs PNA FISH(TM) Test was Associated with an 82% Reduction in Intensive Care Unit Mortality Rates from Staphylococcus aureus Bloodstream Infections
3. AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe
4. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Gram-Negative Bloodstream Pathogens
5. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Staphylococcal Bloodstream Pathogens
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